Nobody likes to admit it, but at some point, everyone has been suckered by a product that they’ve seen on television that promises to do this or that. Once we get it home, however, we discover that this miracle product is actually a total dud. We toss it in the trash and chalk it up to another example of “buyer beware.” When it comes to prescription drugs, though, false promises can be extremely hazardous. Two pharmaceutical giants, Johnson & Johnson and AstraZeneca, settled two separate lawsuits last month. Both lawsuits involve false claims, illegal marketing and unapproved uses of two highly-profitable and extremely popular medications.

Johnson & Johnson paid out $81 million to settle a case that claimed it marketed the epilepsy drug Topamax for unapproved psychiatric uses. Topamax was thrust into the legal system after a Virginia psychiatrist filed a whistle blower lawsuit that assisted the Justice Department in making its case. His lawsuit claimed that the company promoted Topamax for unapproved treatments for alcohol dependence to weight loss and that Johnson & Johnson gave doctors financial kickbacks. J&J pleaded guilty to a single criminal charge. Six million of the settlement will pay a criminal fine, while the rest of the money will resolve civil claims that the company’s marketing of the drug led government health programs to pay for Topamax for unapproved uses.

AstraZeneca’s false marketing came with a steeper price tag: $520 million. The drug giant had marketed its anti-psychotic medication Seroquel for uses that the Food and Drug Administration had not approved. The suit alleged that AstraZeneca had encouraged doctors to prescribe Seroquel for a myriad of unapproved uses, from post-traumatic stress disorder to anger management. Like the J&J suit, the government claimed the company sweetened the deal for doctors by handing over money to prescribe the drug. AztraZeneca, however, has denied the allegations and agreed to pay the $520 million settlement.

Both Seroquel and Topamax also have faced class action suits from patients who claim the drugs didn’t deliver what they promised.

Neurontin, an antiseizure drug manufactured by New York-based pharmaceutical giant Pfizer, is yet another highly prescribed medication with deadly side effects. Approved in 1994 by the Food and Drug Administration to help sufferers of epilepsy with pain and partial seizure prevention, Neurontin has been found to increase suicidal thoughts and actions among patients who use the medication. In fact, the FDA found a startling 80 percent rise in suicidal thoughts and behaviors in data from nearly two hundred studies conducted by the agency.  These studies show Neurontin to be a harmful drug to a certain percentage of the population.

Last July, the first lawsuit against Pfizer went to trial. There are roughly 1200 other cases pending involving Neurontin. The most recent was brought to trial last week in a federal court in Boston, Mass., but both parties reached an agreement before the trial had ended.

Pfizer Inc. also announced that a settlement in a wrongful-death lawsuit was reached for an undisclosed amount on Monday. Linda Shearer, the plaintiff in the lawsuit, claimed her husband Hartley Shearer was prescribed Neurontin to control the effects of his paralysis and that his use of the drug caused him to commit suicide in 2002. The lawsuit also alleged that Pfizer promoted the use of Neurontin even though it was not approved by U.S. regulators and that Pfizer also knew of the suicide risks linked to the product but failed to warn consumers. While the exact details of the settlement are unknown, sources close to the case estimate the final number at no less than $400,000.

This settlement is another setback for Neurontin, a product with a history of legal woes and high-priced lawsuits. Last month, a federal jury found Pfizer guilty of violating an antiracketeering law by marketing Neurontin for off-label uses and awarded damages of $47 million, which is to be automatically tripled under the law. Pfizer said that it plans on filing an appeal and is currently pursuing a postmotion trial. The company also shelled out $430 million to settle a governmental investigation after pleading guilty to a criminal charge linked to the promotion of Neurontin.

Sufferes of diabetes thought they found a golden ticket in Avandia.  Backed with big bucks’ promotion and relentless advertising, Avandia appeared to be a friend to people with diabetes.  Sold as a diabetes management drug, Avandia was pushed on websites like diabetes.com and diabetesmanagment.com, which are sites owned by their maker, GlaxoSmithKline.  The sales skyrocketed and doctors across the country prescribed Avandia to millions.  Yet Advandia wasn’t all it appeared to be.  Two years of investigations and questions about the drug quietly simmered in the background.  GlaxoSmithKline has seen its stock drop this week and the Food and Drug Administration has called for an advisory committee to meet in July to discuss the safety of Avandia.  So what happened to the diabetes wonder drug?

The short answer is that GSK and the FDA have conflicting reports to just how dangerous Advandia can be.  The FDA is under fire for allowing clinical trials of the drug after scientists concluded that Avandia had caused over 80,000 heart attacks from 1999 to 2007, while GSK insists that the proper clinical trials have proven that Avandia is safe.  A Senate committee is currently probing the British pharmaceutical company as well.  Until the FDA’s committee findings however, the agency has informed patients currently using the drug to continue to do so unless their doctors advise them to stop.

Consumer advocates and legal experts however are advising that questions be asked and that the responsible parties be held accountable for a drug that could potentially cause heart attacks. Lawsuits involving wrongful death and injury regarding Avandia have been popping up in courthouse across the country for the past few years.  While the committees continue to meet and the drug companies continue to battle with the FDA, lives of patients hang in the balance.  In short, anything promising to be a wonder drug should be approached cautiously.

Related Information:  California Pharmaceutical Liability Attorney

Do pharmacies make mistakes filling your prescription?  They sure do.  Do drug companies make mistakes labeling their drugs?  They sure do.  And worse, these mistakes which often produce fatal results, are occurring at an alarming rate.  The chance of you becoming the next victim is also increasing.  Here’s why.  The era of your friendly and wise neighborhood pharmacist adorned with lab coat and grey mustache, carefully analyzing your medicinal dose, has all but vanished.  The corner drug store of yesterday has been replaced by the modern day assembly line of chain store pharmacies.  Feeding these chain stores is the multi-billion dollar drug industry, pumping more pharmaceuticals into the stream of commerce than at any time in history and likewise, the chain store pharmacies are in the business of selling those drugs.  Selling has trumped service, with volume, and lots of it, being the bulls-eye.  Now add to this reality the fact that as we get older, we consume more and more of these drugs to treat our progressive ailments.  Based on numbers alone, the odds are increasing that you will become a victim of pharmaceutical negligence.

Pharmacy errors run the gamut from putting the wrong medication or the wrong dosage in the bottle to incorrectly labeling the prescription instructions.  Here are some practical tips to help you from becoming a victim.  If you’re being prescribed a medication for the first time, ask your doctor to identify the medicine, the dosage and the frequency of use.  Write it down so you have something to compare to your prescription later.

If you get a prescription refilled and it looks difference from what you’ve been taking before, tell your pharmacist, “these pills don’t look the same”.  He or she should visually confirm that your prescription is correct.  If the dosage or frequency of taking your medication has changed, call your doctor to confirm the change.

Be especially careful if your prescription calls for compounding.  Compounding is a process where your prescription is formulated or mixed by the pharmacist.  Statistics clearly reveal that the potential for human error significantly increases whenever a pharmacy undertakes the compounding of medications.  Because many compounding errors are not detected until after one suffers an adverse reaction, your best protection is to ask your doctor to recommend the name of a specific compounding pharmacy to formulate your medication.

If the medication you receive from your pharmacy doesn’t come in the familiar brown, plastic pill container but instead, is in what appears to be in the drug manufacturer’s original container with the pharmacy’s label placed over it, compare the pharmacy label with the manufacturer’s label to make sure they are the same.  If they’re not, ask your pharmacist to explain the difference.  The difference may be that one of the labels contains a generic description of drug while the other contains the trade name.  Or the difference may be that you discovered pharmacy negligence before you became a victim.

Negligence by a drug manufacturer may come in the form of its failure to provide adequate warning of adverse reactions, as well as in cases involving antidepressants prescribed for children and teens which have been found to increase the risk of suicide in pediatric patients.

Whether the negligence is committed by a pharmacy or a drug manufacturer, the law provides a remedy allowing for, among other things, money damages.  However, pharmaceutical cases are complex and the laws pertaining to physical and emotional injuries are subject to strict deadlines called Statutes of Limitation.  Anyone who has suffered a pharmaceutical related injury should contact a lawyer immediately to make sure their rights are properly protected.

Obviously the best course of action is always prevention.  Be alert when you receive your next prescription.  Pharmacy negligence and drug manufacturer negligence is an escalating reality.  The Food & Drug Administration says adverse event reporting is as low as 10% for some drugs.  Your vigilance could make the difference between healthy treatment or a disaster.

Agency Also Sends Warning Letter to Manufacturer of Products for Selling Dangerous Product

July 28, 2009 — The United States Food and Drug Administration (FDA) has issued a nationwide alert warning consumers to cease purchasing and consuming body building supplements that contain steroids.  Furthermore, the agency has contacted the manufacturer of the supplements, American Cellular Laboratories Inc., and issued them a warning letter for selling these synthetic steroids as “diet supplements.”  Per the FDA, these products are not diet supplements, but rather misbranded drugs.

See the complete FDA press release

The products listed in the warning letter are as follows:

-TREN-Xtreme
-MASS Xtreme
-ESTRO Xtreme
-AH-89-Xtreme
-HMG Xtreme
-MMA-3 Xtreme
-VNS-9 Xtreme
-TT-40-Xtreme

These products are sold on the Internet and in some stores and the FDA is strongly urging consumers to stop taking these supplements immediately because they contain unapproved new drugs and they have not been recognized as safe and effective.  Consumers taking body building supplements that claim to contain steroids or steroid-like substances should stop taking them immediately. Consumers should also consult a health care professional if they suspect they are experiencing problems associated with the products.

If you or someone you know has suffered an  injury from a dangerous drug or defective product, you may be entitled to compensation for your damages and injuries.